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SanFrancisco99
Aug 11, 2016 11:53AM
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ledenfrog
Aug 11, 2016 12:09PM
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fouremm
Aug 11, 2016 12:47PM
Re: Question....ef·fi·ca... meaning
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ledenfrog
Aug 11, 2016 12:57PM
Re: Question....ef·fi·..... meaning
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KayakerBC
Aug 11, 2016 01:11PM
The following information was copied from ClinicalTrials.gov
DATA MONITORING COMMITTEE (DMC)A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The group can recommend to the study sponsor that the study be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also referred to as a data safety and monitoring board (DSMB). (See also Data Monitoring Committee data element on ClinicalTrials.gov.)
Further study details as provided by Resverlogix Corp:

Primary Outcome Measures:
  • Time to first occurrence of adjudication-confirmed narrowly defined MACE [ Time Frame: 120 weeks ] [ Designated as safety issue: Yes ]
    Narrowly defined MACE(major adverse cardiac event) is defined as a single composite endpoint of CV death or non-fatal MI or stroke


Secondary Outcome Measures:
  • Time to first occurrence of adjudication-confirmed broadly defined MACE [ Time Frame: 120 weeks ] [ Designated as safety issue: Yes ]
    Broadly defined MACE (major adverse cardiac event) is the occurrence of any of the following: CV death, non-fatal MI, hospitalization for CVD events, or stroke

  • Group difference in all-cause mortality [ Time Frame: 120 weeks ] [ Designated as safety issue: Yes ]
  • Percent change in apoA-I concentration over time within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
  • Percent change in apoB concentration over time within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
  • Percent change in LDL-C concentration over time within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
  • Percent change in HDL-C concentration over time within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
  • Percent change in TG concentration over time within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
  • Change in HbA1c over time within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
  • Change in fasting glucose over time within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
  • Change in fasting insulin over time within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
  • Change in alkaline phosphatase (ALP) over time within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
    including isoforms for whole population and quartiles of ALP baseline concentration

  • Change in kidney function in population [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
    baseline estimated glomerular filtration rate (eGFR) <60 mL/min/1.7m2

  • Incidence of AEs and Serious AEs within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Percent change in hsCRP within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
Percent change in fibrinogen within and between treatment groups [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
  • Transcription (messenger RNA [mRNA]) change in whole blood [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Health Related Quality of Life (HRQOL) as measured using the EQ-5D-5L [ Time Frame: 122 weeks ] [ Designated as safety issue: No ]

As noted above

The group can recommend to the study sponsor that the study be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose.

The group concluded that the study should continue. According to the clinical trials website, the DSMB would have been formed with a charter which presumably have predifined guidelines for evaluating safety. I suspect that the issues evaluated are specified above in the primary and secondary outcome measures. The list above as copied from the website indicates which issues are designated as safety issues.

Another milestone is met! An affirmation that RVX is safe for continued testing in 2400 trial participants - we move on to the next stage - miraculous trial results to validate this pioneering and life saving therapy - time for some price movement.

Chicagoest

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